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It is Not All About the Data
The estimated cost of running a clinical trial in the United States ranges from $20 million for a Phase I trial, to $100 million for a Phase III trial. Each year, sponsors invest millions of dollars to improve the efficiency and reduce the costs associated with running trials. Site efficiency and productivity can be improved by centralizing information, providing recruitment and screening tools, automating scheduling, managing finances, and providing accurate reporting and metrics. Historically, suppliers of Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) have focused explicitly and exclusively on managing the data involved in clinical trials. The problem is, however, that the data is only part of the equation…at least equally important are the documents, work items, notifications, and other elements of collaboration.
Management of essential trial documentation is, indisputably, one of the most time consuming and costly activities associated with conducting a clinical trial. ICH E6 guidance on Good Clinical Practice (GCP) specifies an inventory of over 200 discrete documents that must be managed before, during and after the trial. Any or all of these documents must be available for audit by the sponsor and for inspection by the regulatory authorities, and considering the massive volumes of documentation involved in the process, the effective management and exchange of study documentation can have a significant impact on the cost and time to complete a clinical trial.
Yet despite the costs in time, effort and money, the trial master file (TMF) is often still managed through a combination of paper and simple shared folders, scattered across many locations in various countries. Management of a paper TMF is incredibly resource intensive – documents are handled by multiple people from collection at the investigational site to placement in regulatory binders. TMF documents are tracked manually using spreadsheets or checklists which provide little visibility into what has been collected to-date and what is missing. Often, duplicate copies are collected and filed unnecessarily while others expire or go uncollected. The result is decreased operational efficiency, higher costs and the risk of regulatory noncompliance,
and possibly approval delays.